Registration Dossier
Registration Dossier
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EC number: 203-961-6 | CAS number: 112-34-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Full study report available. Well documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-(2-butoxyethoxy)ethanol
- EC Number:
- 203-961-6
- EC Name:
- 2-(2-butoxyethoxy)ethanol
- Cas Number:
- 112-34-5
- Molecular formula:
- C8H18O3
- IUPAC Name:
- 2-(2-butoxyethoxy)ethanol
- Details on test material:
- - Name of test material (as cited in study report): Diethylene glycol mono butyl ether
- Physical state: liquid
- Analytical purity: >99.5%
- Other: EK Acc #:902423. TEX#:56-21. PM#:1800. HS&HFL La#:79-417
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Weight at study initiation: 15-17g
- Fasting period before study: Two studies conducted, with and without fasting. Studies conducted 2 months apart. When fasting used 16-20hrs.
- Housing: individual in suspended wire bottomed cages.
- Diet (e.g. ad libitum): ad libitum prior to fasting
- Water (e.g. ad libitum): ad libitum
- Acclimation period:Yes
ENVIRONMENTAL CONDITIONS
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No further information
- Doses:
- Not specified but within the range 2.6-168mM/kg and increasing by a factor of 2 between doses.
- No. of animals per sex per dose:
- 5
- Control animals:
- other: no, but 8 other compounds tested in same study which acted as reference controls
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: General appearance and activity, pharmacologic and toxicologic signs and mortality checked daily except weekends. Appearance of stools/urine also noted. Weighings done before dosing and at end of observation period.
- Necropsy of dead animals performed: yes, gross pathology.
- Necropsy of survivors performed: yes - Statistics:
- LD50 calculated with its 95% confidence interval using the method of Thompson and Weil (Biometrics 8, p51-4 (1952)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 410 mg/kg bw
- 95% CL:
- > 1 470 - < 3 920
- Remarks on result:
- other: Results for fasted animals
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 530 mg/kg bw
- 95% CL:
- > 3 560 - < 8 570
- Remarks on result:
- other: Results for fed animals
- Mortality:
- Deaths occured within 1-10 days but most within 1-3 days
- Clinical signs:
- other: Clinical signs of toxicity for both fed and fasted animals were inactivity, labored breathing, rapid respiration, anorexia, slight to moderate weakness, tremors, prostration and death. Animals that died exhibited bloody urine, and/or blood in the stomac
- Gross pathology:
- Dead animals revealed bloody urine and blood in stomach and intestines during pathology.
- Other findings:
- No other findings reported
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, this substance would not be classified for acute toxicity in accordance with the current EU guidelines.
- Executive summary:
In a single dose acute oral toxicity study, male CD-1 mice were exposed to 2 -(2 -butoxyethoxy)ethanol. The experiment was repeated in duplicate, once with fasted animals and once with fed animals. The LD50 values are shown below. Sub-lethal effects included labored breathing, rapid respiration, anorexia, slight to moderate weakness, tremors and prostration. Based on the results of this study, this substance would not be classified for acute toxicity in accordance with the current EU guidelines (Directive 67/548 or Regulation 1272/2008.)
Results synopsis
LD50 (fasted animals): 2410mg/kg
LD50 (fed animals); 5530mg/kg
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